浙江省肠道病毒71型疫苗安全性监测分析  

Analysis on surveillance of adverse events following immunization for enterovirus 71 vaccine in Zhejiang

作　　者：潘雪娇[1] 符剑[1] 沈灵智[1] 谢淑云[1] Pan Xuejiao;Fu Jian;Shen Lingzhi;Xie Shuyun(Institute of Immunization Program, Zhejiang Prorincial Center for Disease Control and Prevention, Hangzhou 310051,China)

机构地区：[1]浙江省疾病预防控制中心免疫规划所,杭州310051

出　　处：《国际流行病学传染病学杂志》2019年第2期156-159,共4页International Journal of Epidemiology and Infectious Disease

基　　金：浙江省医药卫生科技计划(2019KY053).

摘　　要：目的评价肠道病毒71型(EV71)疫苗在浙江省使用后的安全性.方法通过中国疑似预防接种异常反应(AEFI)信息管理系统,收集2016-2017年在浙江省接种EV71疫苗的儿童接种后发生的AEFI情况,采用描述性流行病学方法进行评价分析.结果浙江省2016-2017年累计报告接种EV71疫苗后发生的AEFI个案629例.报告发生率119.56/10万剂,其中异常反应报告71例,报告发生率13.50/10万剂,男性多于女性(1.13∶1),以13~24月龄内为主(269例,占42.77%),2-4月份占全年报告总数的35.93%.金华市报告最多(162例),主要集中在第1剂次(465例,占73.93%),55.64%(350例)的AEFI发生在接种后1d内.临床损害以发热、红肿、硬结等一般反应较多,异常反应则以过敏性皮疹为主(38例,报告发生率7.22/10万剂),82.67%的病例最终痊愈.结论浙江省EV71疫苗安全性良好,但应进一步加强监测.Objective To evaluate the safety of enterovirus 71(EV71) vaccine in Zhejiang.Methods The adverse events following immunization(AEFI)for EV71 vaccine in Zhejiang Province during 2016-2017 were collected through the AEFI information system.The data were analyzed by descriptive epidemiological methods.Results There were 629 AEFI cases reported after immunization for EV71 vaccine in Zhejiang in 2016-2017,and the estimated incidence rate was 119.56 per 100 000 doses.In these cases,71 had rare vaccine reactions with the estimated incidence rate of 13.50 per 100 000 doses.The ratio of male to female was 1.13∶1.A total of 269 (42.77%) AEFIs happened in the infants at the age of 13-24 months,and 35.93% of cases occurred during February and April.Jinhua City had the largest number of reported cases(162 cases).EV71 vaccine adverse reactions mainly happened after the 1st dose (465 cases,73.93%) and within 1 day after vaccination (350 cases,55.64%).The main symptoms of common vaccine reactions were fever,local swelling and indurations.The main diagnoses of rare vaccine reactions were anaphylactic rashes with the estimated incidence rate of 7.22 per 100 000 doses (38 cases).Of all the cases,82.67% had good prognosis.Conclusions The EV71 vaccine in Zhejiang is safe.However,the AEFI surveillance of EV71 vaccine should be strengthened.

关 键 词：接种 EV71疫苗 不良反应 评价 

分 类 号：R186[医药卫生—流行病学]